Scientist, Analytical Development Job Description Template
Our company is looking for a Scientist, Analytical Development to join our team.
- Selected candidate will report to the Director of Analytical Development;
- Develop analytical testing strategies based on provided customer technical package and/or process development synthetic routes;
- Collaborate with customers and other functional areas to advance projects through development;
- Author reports and review data;
- Execute method validation protocols for the CGMP release of drug substance batches;
- Develop new analytical methods;
- Assess customer methods for validation readiness;
- Characterize process and product related impurities in cell product and viral vector in collaboration with process development teams;
- Serves as a technical mentor for junior staff and leverages technical expertise as a functional resource/trainer;
- Contributes significantly and independently to project work which may include multiple projects within functional area;
- Proactively analyses manufacturing issues and coordinates potential resolution with the CMC team;
- Identifies critical product quality attributes in RCT drug product through forced degradation and structure-function related studies;
- Understands project timelines and deliverables and plans/coordinates project work accordingly with departmental, functional and external stakeholders;
- Assists with development of project strategy and communicates complex data/decisions within department and cross functionally as necessary;
- Responsible for integrating scientific/technical efforts around cross-functional issues.
- PhD in biochemistry, cell and molecular biology or related pharmaceutical science; 0-2 years relevant industry experience;
- Understanding of viral transduction process and viral analytics is strongly preferred;
- Extensive knowledge of hematopoietic stem cell biology and/or red blood cell physiology is strongly preferred;
- Understanding and experience of analytical assay validation is a plus.